NL-OMON50828已完成不适用
A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Food Effect of THB001 in Healthy Subjects - CS0366 - THB FIH
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subjects must understand the nature of the study and must provide signed and
- •dated written informed consent in accordance with local regulations before the
- •conduct of any study-related procedures.
- •2. Healthy as determined by the Investigator, based on a medical evaluation
- •including medical history, physical examination, laboratory tests and ECG
- •recording. A subject with a clinical abnormality or laboratory parameters
- •outside the reference range for the population being studied may be included
- •only if, in the opinion of the Investigator, the finding is (a) unlikely to
- •introduce additional risk to the subject, (b) will not interfere with study
- •procedures or confound study results, and (c) is not otherwise exclusionary
- •(see Exclusion Criteria).
- •3. In Part 1 and 2, men and women aged 18-65 years (inclusive) at the time of
- •Screening will be enrolled, and in Part 3 vasectomized men and women aged 18-65
- •years (inclusive) at the time of Screening will be enrolled.
- •4. Women of child-bearing potential must agree not to attempt to become
- •pregnant and to use a highly effective form of hormonal (excluding oral
- •contraceptives) or non-hormonal birth control, which entails the use of a
- •non-hormonal intra-uterine device/system in combination with a barrier method
- •(e.g. condom, diaphragm, cervical cap with spermicide) or abstinence during the
- •study and for 90 days after the (last) study drug administration.
- •Postmenopausal women must have had >=12 months of spontaneous amenorrhea (with
- •documented follicle-stimulating hormone (FSH) >=30 mIU/mL). Surgically sterile
- •women are defined as those who have had a hysterectomy, bilateral ovariectomy,
- •or bilateral tubal ligation. Women who are surgically sterile must provide
- •documentation of the procedure by an operative report or by ultrasound. All
- •women must have a negative pregnancy test result on Day -1 before (first)
- •administration of study medication.
排除标准
- •1. A positive urine drug screen/alcohol breath test at Screening or Day -1 of
- •the (first) treatment period.
- •2. A positive Hepatitis B surface antigen or positive Hepatitis C antibody
- •result at Screening.
- •3. A positive test for human immunodeficiency virus (HIV) antibody at Screening.
- •4. Alanine aminotransferase, aspartate aminotransferase, or total bilirubin
- •levels greater than the upper limit of normal (ULN) at Screening or Day -1 of
- •the (first) treatment period. One test result up to 1.25 x the ULN is allowed.
- •One retest at Screening and on Day -1 of the (first) treatment period is
- •allowed. Subjects with Gilbert*s Syndrome are permitted to have total bilirubin
- •values outside the 1.25 x the ULN, as judged by the Investigator, as long as
- •the AST and ALT are within normal limits (WNL).
研究者
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